sanofi

Final no for Sanofi’s Zaltrap

pharmafile | March 25, 2014 | News story | Medical Communications, Sales and Marketing |  NICE, Sanofi, Zaltrap, colorectal cancer 

A price cut and an appeal has not been enough to sway NICE into recommending Sanofi’s cancer drug Zaltrap after it once again rejected the treatment in new guidance issued today.

Zaltrap (aflibercept) has not been recommended for treating metastatic colorectal cancer that is resistant to or has progressed after use with the chemotherapy agent oxaliplatin.

Although NICE’s independent committee considers Zaltrap to be ‘a clinically effective treatment’, it says that it still could not be considered a cost-effective use of NHS resources – even when the patient access scheme submitted by Sanofi was taken into account.

The Institute received an appeal on its final draft guidance for this appraisal from Sanofi – the appeal was heard on 23 January 2014 but eventually dismissed on all points.

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Sir Andrew Dillon, chief executive of NICE, says: “We have already recommended six treatments for various stages of colorectal cancer and are disappointed not to be able to add [Zaltrap] as another treatment option for this stage of the disease.

“However, we have to be confident that the benefits that drugs offer patients really do justify what the NHS will have to pay for them. Although the independent committee considered aflibercept to be a clinically effective treatment, it could not be considered a cost-effective use of NHS funds.”

The list price of a vial of 100mg of Zaltrap is £295.65, with the list price of a vial of 200mg is £591.30. This would have been lower, given the price cut Sanofi offered, but just how much this would reduce the cost is ‘commercial in confidence’.

NICE believes that the most plausible ICER was higher than the normally acceptable maximum range of £20,000 – 30,000 per QALY gained.

The committee noted Sanofi’s estimated ICER assumptions was £44,000 per QALY gained (for age 60), but would increase for the higher age bracket, possibly as much as £51,000.

Steve Oldfield, Sanofi’s managing director of UK and Ireland, says: “We are extremely disappointed NICE has not approved aflibercept, particularly given that based on the same basic evidence, the Scottish Medicines Consortium accepted aflibercept.

“Sanofi wanted NICE to be able to approve aflibercept for patients in England and Wales and offered a patient access scheme as part of the appraisal.”

Sanofi adds that around 4,000 patients in England and Wales could receive second line treatment for metastatic colorectal cancer.

Ben Adams

 

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